PMCPA Case Analysis

Over 2,000 real rulings β€” analysed for what they mean to your team. Published every day.

All Cases PMCPA Case of the Week PMCPA Cases

Showing 1914 cases

2013
CASE
AUTH/2676/11/13 Janssen

AUTH/2676/11/13: Member of the public v Janssen β€” Clinical trial disclosure for Incivo (telaprevir) (No breach)

Public complaint alleged Janssen failed to disclose Incivo (telaprevir) trial results. Panel found the relevant J&J-sponsored UK-involved study was published within the…

2013
CASE
AUTH/2654/11/13 Bristol-Myers Squibb

Bristol-Myers Squibb: delayed clinical trial results disclosure for Onglyza (AUTH/2654/11/13) alongside no-breach findings for Nulojix and Yervoy (AUTH/2656/11/13)

Public complaint about trial transparency data. PMCPA found a breach for delayed disclosure of one Onglyza UK-involved trial (Clauses 21.3 and 9.1,…

2016
CASE
AUTH/2833/4/16 Bausch

AUTH/2833/4/16: ALK-AbellΓ³/PMCPA Director v Bausch & Lomb β€” consultant slide (β€˜New Design’) held to breach prior undertaking

A consultant presented a slide calling Emerade 500mcg β€˜New Design’ after Bausch & Lomb had given undertakings not to describe the product…

2016
CASE
AUTH/2871/8/16 Janssen ⭐ Case of the Week

Janssen voluntary admission: Crohn’s β€œdisease awareness” campaign ruled pre-licence promotion for ustekinumab (AUTH/2871/8/16)

Janssen admitted a Crohn’s awareness campaign sent to UK gastroenterologists promoted ustekinumab for an unlicensed indication and was not UK-certified. PMCPA found…

2016
CASE
AUTH/2844/5/16 Amdipharm Mercury Company

Amdipharm Mercury voluntary admission: rep sent uncertified promotional email with unsubstantiated Lutrate claim (AUTH/2844/5/16)

AMCo admitted a rep sent an unapproved promotional email for Lutrate containing a confusing, unscientifically valid and unsubstantiated claim. PMCPA found breaches…

2016
CASE
AUTH/2880/10/16 Bristol-Myers Squibb Pharmaceuticals

AUTH/2880/10/16: Anonymous (non-contactable) v Bristol-Myers Squibb – Opdivo (nivolumab) and alleged pre-licence promotion to MPs (No breach)

Anonymous consultant alleged BMS promoted Opdivo pre-licence/unlicensed (lymphoma) via MPs and entertained them. Panel had concerns about MP interactions but found allegations…

2016
CASE
AUTH/2862/8/16 Takeda

Takeda: funding linked to product advocacy implied in email about exhibition stand sponsorship (AUTH/2862/8/16)

Anonymous complaint about a nurse-led consultancy. Panel found no proven breach for therapy review grants, but ruled breaches after an email implied…

2015
CASE
Novo Nordisk

Novo Nordisk websites: patient video β€˜utterly transformed my life’ ruled to raise unfounded hopes; unclear sponsorship wording and late recertification

PMCPA found Novo Nordisk in breach for a patient video implying a once-daily injection β€˜utterly transformed’ life (unfounded hope), unclear sponsorship disclosure…

2017
CASE
AUTH/2928/1/17 Novartis Pharmaceuticals UK ⭐ Case of the Week

Anonymous v Pfizer and Novartis (AUTH/2928/1/17 & AUTH/2929/1/17): Ultibro promotion, PV concerns and breach of undertaking

PV consultant alleged off-label exacerbation-risk promotion for Ultibro. Panel found breaches for a FLAME β€œbusiness card” and unclear GOLD briefing, including breach…

2015
CASE
AUTH/2783/7/15 Stirling Anglian

Stirling Anglian: β€˜Advisory board’ in Germany ruled promotional, with inappropriate hospitality and payments (AUTH/2783/7/15)

Media reports triggered a PMCPA case about a Germany meeting for UK NHS payors. The Panel ruled it wasn’t a genuine advisory…

2017
CASE
AUTH/2978/9/17 Janssen

Janssen pre-licence promotion finding over IL-23 symposium (Tremfya/guselkumab) at BAD 2017 (AUTH/2978/9/17)

PMCPA ruled Janssen promoted unlicensed guselkumab via a BAD 2017 symposium that lacked genuine two-way scientific exchange and appeared product-focused. Breaches of…

2007
CASE
AUTH/1992/4/07 Sanofi

AUTH/1992/4/07: Pharmacist practitioner v Sanofi-Aventis – conduct of representative (Lantus/Acomplia) – No breach

Complaint alleged a Sanofi-Aventis rep misrepresented ADA/EASD guidance for Lantus and confused Acomplia study data/positioning in type 2 diabetes. Panel could not…

2007
CASE
AUTH/2074/12/07 AstraZeneca

AstraZeneca rep left Symbicort sales literature during child’s GP appointment: breaches of Clauses 9.1 and 15.2 (AUTH/2074/12/07)

AstraZeneca representative used a private GP consultation (for his child) to leave Symbicort promotional material on the doctor’s desk. PMCPA ruled breaches…

2007
CASE
AUTH/2045/9/07 Novo Nordisk ⭐ Case of the Week

AUTH/2045/9/07: Lilly v Novo Nordisk – Levemir advertorial in Pulse and β€œweight advantages” claim

Lilly challenged a Levemir advertorial in Pulse. PMCPA found the β€œWeight advantages with Levemir” section misleading/ambiguous and inconsistent with the SPC. Breaches…

2007
CASE
AUTH/1993/4/07 AstraZeneca

AUTH/1993/4/07: Anonymous v AstraZeneca β€” alleged inappropriate hospitality (no breach)

Anonymous alleged AstraZeneca funded inappropriate hospitality at a Midlands Psychiatric Research Group meeting. Panel found the event primarily educational and no evidence…

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